Wockhardt's Chikalthana unit woes set to abate

After reeling under a series of production bans at its plants, the Mumbai-headquartered drug major Wockhardt is slowly getting back into the business.

While the US drug regulator Food and Drug Administration (FDA) completed a 10-day long inspection of its Chikalthana plant in Maharashtra on Wednesday (March 18), the facility is getting ready to begin production of 10 products for the European market after being cleared by the British regulator UK Medicines and Healthcare Regulatory Agency (MHRA).

A senior company official told dna that its Chikalthana plant, which stopped production completely following import alerts by foreign regulators, is breathing back to life with some production from next week.

"The company had struck an outsourcing deal with a foreign company to buy products soon after MHRA put its Chikalthana facility on import alert. Now that the Chikalthana plant has received MHRA clearance, Wockhardt will start manufacturing some portion at its plant while it would continue to buy under the outsourcing deal," said the official.

In a statement to BSE Ltd, Wockhardt said on Wednesday that the recent inspection at the Chikalthana site (Aurangabad) was a follow-up inspection by the US FDA as an outcome of completion of GMP (good manufacturing practice) remediation submitted by Wockhardt in October 2014.

"The efforts for data security control have been thoroughly verified during the inspection and have been appreciated as it is qualified and executed since September 2013. There were no findings with respect to data security and control measures in laboratory and manufacturing. The observations on Form FDA 483 are on products manufactured prior to execution and implementation of GMP remediation programme," said the statement.

The Wockhardt official said the inspection was spread over the three departments of quality assurance, quality control and manufacturing. "Our feedback is that we would get a final nod from US FDA soon."

Meanwhile, MHRA has cleared 10 products of the 12 products, and asked the company to validate processes and submit fresh data once again in the other two products.

Over the last three months, the Wockhardt stock has climbed up steadily from Rs 940 on December 18, 2014, to Rs 1,878 on Wednesday, on the BSE. Wockhardt's share touched a 52-week high of Rs 1,948 on March 17.

The drugmaker has been tackling a number of regulatory issues with foreign regulators over past couple of years. In 2013, the US FDA issued an import alert on the company's two facilities, Waluj and Chikalthana, both in Aurangabad. However, the US FDA later allowed the company to manufacture five drugs to avoid a drug shortage in the US market. Similarly, the MHRA also withdrew its quality certification to the Chikalthana plant in 2013 after it identified deviations in the facility. The regulator, which later issued a restricted GMP to the Chikalthana unit, also initiated a recall of 16 prescription-only drugs made in that facility, of which the agency later allowed 10 drugs to be manufactured to avoid a shortage in the UK market.